Clinical Trial 24176

• Overview

  Study Title:

  A Phase 1, First-in-Human, Open Label Study Evaluating Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy of ABBV-438 in Adult Subjects With Relapsed or Refractory Multiple Myeloma

  Summary:

  The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics (PK) and preliminary efficacy of ABBV-438 as a monotherapy in participants with Relapsed or Refractory Multiple Myeloma (R/R MM)

  Objective:

  Primary Objectives: - To evaluate the safety and tolerability of ABBV- 438 administered as monotherapy in subjects with R/R MM - To identify the recommended Phase 1 expansion dose(s) of ABBV-438 Secondary Objectives: - To evaluate the preliminary efficacy of ABBV-438 as monotherapy in subjects with R/R MM - To characterize the pharmacokinetics of ABBV-438 administered as monotherapy in subjects with R/R MM

• Treatments

  Therapies:

  Antibody-drug conjugate (ADC)

  Medications:

  ABBV-438 ()

• Inclusion Criteria

  Inclusion Criteria:
  • Has relapsed or refractory Multiple Myeloma (MM) with documented evidence of progression during or after the participant's last treatment regimen based on the investigator's determination of the standard International Myeloma Working Group (IMWG) (2016) response criteria: (a) Relapsed defined as previously treated myeloma that progresses and requires initiation of salvage therapy (b) Refractory defined as disease that is nonresponsive (failure to achieve minimal response) while on last therapy, or progresses within 60 days of last therapy.
  • Has measurable disease at screening, defined by at least 1 of the following within 28 days prior to enrollment: (a) Serum M-protein >= 0.5 g/dL (>=5 g/L); OR; (b) Urine M-protein >= 200 mg/24 hours; OR;(c) Involved serum free light chain (sFLC) >= 10 mg/dL (100mg/L), provided serum FLC ratio is abnormal; (d) Must have had 3 or more prior lines of therapy with exposure to a proteasome inhibitor (PI), an immunomodulatory imide drugs (IMiD), and an anti-CD38 therapy and are intolerant to, or unable to access, available therapies that are known to confer clinical benefit to participants with relapsed or refractory (R/R) MM. Note: A line of therapy consists of relapsed or refractory 1 complete cycle of a single agent, a regimen consisting of a combination of several drugs, or a planned sequential therapy of various regimens.
  • Other criteria may apply

• Exclusion Criteria

  Exclusion Criteria:
  • Known history of Central Nervous System involvement by MM.
  • History of idiopathic pulmonary fibrosis, organizing pneumonia (e.g., bronchiolitis obliterans), drug-induced pneumonitis, or idiopathic pneumonitis.
  • Other exclusions may apply

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